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Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) is proud to announce the publication of a pivotal research article in the prestigious Journal of Cosmetic Dermatology .
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Sirona Biochem
Investor Insight
Sirona Biochem is on track to commercialize its proprietary anti-aging product, increasing shareholder value and enhancing profitability.
Overview
Sirona Biochem (TSXV:SBM,FSE:ZSB,US OTC:SRBCF) is a biotechnology company with an innovative platform for developing safer, more effective cosmetic and therapeutic active ingredients. Sirona Biochem’s strategy involves bringing innovative patented compounds to market while also engaging in partnerships to license or sell them to prominent global enterprises. In exchange, receiving income generating sales, front-end fees, milestone payments, and ongoing royalties.
Sirona’s technology is based on proprietary carbohydrate chemistry developed by the company’s wholly-owned French subsidiary research and development (R&D) laboratory TFChem. This carbohydrate chemistry can improve the safety and efficacy of carbohydrate-based molecules, which have broad application potential for the development of therapeutics and cosmeceuticals. Examples of commercially available carbohydrate-based drugs include viral neuraminidase inhibitor Tamiflu, and Johnson & Johnson’s (NYSE:JNJ) SGLT2 inhibitor Invokana™.
The company has an exclusive global licensing agreement with Allergan Aesthetics, an AbbVie company (NYSE:ABBV), to commercialize topical skin care treatments for dyschromia based on Sirona’s patents for TFC-1067 and related family of compounds. TFC-1067 is a very potent but safe dark spot remover and a breakthrough in the industry.
Sirona’s commercial launch of a serum containing our GlycoProteMim™ in 2025 is on track. The company’s Paris-based cosmetic branding expert has developed a compelling strategy to position this product as a premium offering in the anti-aging market highlighting GlycoProteMim's™ rejuvenating properties. GlycoProteMim™ serum will provide consumers with aging skin a breakthrough solution, delivering unmatched benefits without any observed adverse effects.
Sirona is led by a highly experienced team of biotechnology professionals. The company’s chief scientific officer Dr. Géraldine Deliencourt-Godefroy is an award-winning synthetic chemist and the founder of the French biotechnology company TFChem. Her scientific research in carbohydrate chemistry has led to the discovery of new drug families and the development of drug candidates for diabetes and obesity, cosmetic ingredients and biological adjuvants. She is the recipient of the acclaimed Francinov Research and Innovation Medal, the French Ministry of Research Award and the French Senate Award.
Technology Platform
Sirona’s technology platform is based on proprietary carbohydrate chemistry. Carbohydrate molecules play a central role in cell-to-cell communication and can interact with proteins, hormones, viruses, toxins and bacteria. In this way, carbohydrates perform a variety of essential biological functions in the human body, making them valuable components for the development of therapeutics and cosmeceuticals.
While they have broad application potential, carbohydrates are extremely challenging to develop due to their inherent instability. Using chemistry techniques originally developed by TFChem, Sirona has overcome the challenge of stabilizing carbohydrates to develop safer, more effective cosmetic and therapeutic active ingredients.
Sirona is exploring multiple commercial opportunities and partnerships for its carbohydrate technology platform and currently has two streams of product line: cosmetics and therapeutics.
Company Highlights
- Proven technology platform based on proprietary carbohydrate chemistry leading to a pipeline of products across a broad range of applications in cosmetics and pharmaceuticals all based on 20 years of research and development.
- Signed global exclusive licensing deal with Allergan Aesthetics, an AbbVie [NYSE: ABBV] company, for TFC-1067 and related family of compounds for the treatment of dyscromiadyschromia.
- Under the license agreement, Sirona will receive payments on achievement of milestones and royalties on product sales. Seventeen years duration for TFC-1067 patents.
- Strong worldwide IP portfolio, including North America, European Union and Asia.
- Developing disruptive solutions for anti-aging (US$12.5 billion), dyschromia(US$7.5 billion), and cellulite treatment (US$ 1.4 billion).
- Preparing for a planned commercial launch of anti-aging anti-wrinkle skincare product first quarter 2025 containing Sirona’s GlycoProteMim™ ingredient.
- State-of-the-art, laboratory in Paris France with award winning scientific team.
Key Business Segments
TFC-1067
June 13 2022 Sirona announced it has entered into a global licensing agreement with Allergan Aesthetics, an AbbVie company (NYSE:ABBV), pursuant to which Allergan Aesthetics will develop and commercialize topical skin care treatments based Sirona’s TFC-1067 and related family of compounds. Work is underway to bring product(s) containing TFC-1067 to commercial sales. Sirona will receive payments on the achievement of milestones and royalties on product sales.
GlycoProteMim™
GlycoProteMim™ (TFC-1326) is a revolutionary compound that offers remarkable anti-aging results and stands out as a beacon of innovation and safety. Unlike traditional alternatives such as toxins, dermal fillers, and retinoids, GlycoProteMim™ offers a unique solution that is safe and effective in reversing skin aging.
GlycoProteMim™ heightens cellular response to reactive oxygen species (ROS) and boosts SOD2. The compound also enhances hyaluronic acid synthesis and increases fibroblast proliferation, fortifying the collagen network.
Product Highlights:
- Safe for All Skin Types: GlycoProteMim™ is designed for all skin types. It has been proven to be tolerated by 100 percent of participants in clinical trials.
- Natural Progression, Not Injection: GlycoProteMim™ is a topical application and does not require invasive injections.
- Anti-Aging Efficacy: The product is loaded with powerful anti-inflammatory effects. It reverses aging and repairs skin, offering a comprehensive and permanent solution.
Multifaceted Benefits: GlycoProteMim™ outshines alternatives by helping improve skin laxity and quality and providing UV protection while enhancing the skin barrier. Retinoids, while effective, come with challenges like skin irritation and a lengthy onset period, making GlycoProteMim™ a more versatile and user-friendly alternative.
Sirona’s subsidiary, TFChem, has successfully received formulations for its eagerly awaited GlycoProteMim™ based anti-aging serum from its formulation partner, Global Beauty Consulting. The formulation intends to define the brand and lay the foundation for a broader range of products. This formulation will undergo standard safety evaluations and be used in the upcoming clinical trial. Sirona plans to launch the product in early 2025, ensuring compliance with regulatory standards in the European, US, and Canadian markets.
Cellulite Treatment, Wound care, and Keloid Treatments
Sirona’s scientists have identified new molecules underscoring its commitment to comprehensive skincare solutions developed by TFChem for the treatments of cellulite, wound care and keloids. Research plans have been developed and will be implemented when sufficient resources become available. There is a massive unmet need for effective treatments in these areas spanning both cosmetics and therapeutic markets.
Melasma Therapeutics
Sirona has retained the rights to commercialize TFC-1067 and related compound TFC-1394 as a therapeutic for the treatment of melasma. The potential exists to produce an effective therapeutic agent free of hydroquinone.
Management Team
Dr. Howard J. Verrico - CEO and Chairman of the Board
Dr. Verrico obtained his medical degree from the University of Toronto in 1985 and has been a member of the College of Physicians and Surgeons of British Columbia since July 1986. Dr. Verrico has extensive experience as a venture capitalist in the junior capital markets. He has acted as a venture capitalist for over 30 years, funding numerous start-ups and early-stage companies both in the private and public marketplace. He is the founder of Sirona Biochem building the company by investing his personal funds starting in 2006, He has accumulated his large share position through personal share purchases. He currently is solely focused on the success and growth of SIRONA Biochem as it enters a stage of rapid growth.
Géraldine Deliencourt-Godefroy - Chief Scientific Officer
Dr. Géraldine Deliencourt-Godefroy is an award-winning synthetic chemist and the founder of French-based biotechnology company TFChem. Since the acquisition of TFChem by Sirona Biochem in March 2011, Dr. Deliencourt-Godefroy has assumed the role of Chief Scientific Officer. Her scientific research in carbohydrate chemistry has led to the discovery of new drug families and the development of drug candidates for diabetes and obesity, cosmetic ingredients and biological adjuvants. Previous to founding TFChem, Dr. Deliencourt-Godefroy was a scientific leader at INSA (National Institute of Applied Sciences) in Rouen, France, where she developed a new technology on stabilized carbohydrates. Previous roles also include a post-doctoral position at the University College London and doctoral research at the Research Institute of Fine Organic Chemistry in Rouen, France. Dr. Deliencourt-Godefroy received a PhD and Masters in Organic Chemistry as well as her business degree from the University of France. She is the author of several publications and patents and is also the recipient of the acclaimed Francinov Research and Innovation Medal, the French Ministry of Research Award and the French Senate Award.
Christopher Hopton - Chief Financial Officer
Christopher Hopton brings 28 years of financial management and operations expertise to the company. His extensive background includes financial planning, accounting policy, and business process improvement. As a business investment and finance consultant, he has worked with multiple public and private companies. Noteworthy roles include serving as chief financial officer at Central Resources and Rio Silver, as well as a division controller at Canadian Airlines, where he managed a $200 million annual operating budget. He played a key role in the restructuring of 360 Networks, leading to its acquisition by Bell Canada. Hopton holds a Bachelor of Business Administration from Simon Fraser University and is a Certified Professional Accountant.
Sirona Biochem Announces Publication of Groundbreaking Study on TFC-1326 Compound in the Journal of Cosmetic Dermatology
The article, titled "TFC-1326 Compound Reduces Clinical Signs of Skin Aging: Evidence From In Vitro Human Adipose and Skin Models and Pilot Clinical Trial," highlights the groundbreaking efficacy of Sirona's proprietary compound TFC-1326 in reducing visible signs of skin aging.
Read the full article here:
Access the Study: TFC-1326 Compound Reduces Clinical Signs of Skin Aging. Evidence From In Vitro Human Adipose and Skin Models and Pilot Clinical Trial
The study, conducted by leading scientists at Diva Expertise in collaboration with Sirona Biochem, presents compelling data demonstrating the ability of TFC-1326 to target key mechanisms of skin aging.
Key Findings
Using advanced in vitro human adipose and skin models, as well as a pilot clinical trial, TFC-1326 was shown to:
- Enhance skin elasticity and firmness
- Stimulate the production of collagen and other extracellular matrix components
- Reduce the appearance of fine lines and wrinkles
Clinical Trial Results
The pilot clinical trial with a 1% TFC-1326 topical cream provided robust evidence supporting its safety and efficacy. Key results included:
- Visible improvement in skin texture, hydration, and overall appearance
These findings reinforce the compound's potential as a next-generation anti-aging solution.
Statements from Leadership
"Our innovative approach to carbohydrate chemistry has once again delivered transformative results," said Dr. Howard Verrico, CEO of Sirona Biochem. "The publication of these findings in the Journal of Cosmetic Dermatology is a testament to the cosmeceutical benefits of TFC-1326 on aged skin. We believe this compound has the capacity to redefine anti-aging skincare solutions."
"This marks a significant milestone for Sirona Biochem," added Dr. Verrico. "We are actively advancing discussions with potential commercial partners while also laying the groundwork to launch our own product, ensuring this groundbreaking technology reaches the market and delivers its full potential to consumers globally."
TFC-1326 and Trademark Information
TFC-1326 and its salt form, TFC-1325, are being marketed under the trademarked name GlycoProteMim .
Read the full study here:
TFC-1326 Compound Reduces Clinical Signs of Skin Aging. Evidence From In Vitro Human Adipose and Skin Models and Pilot Clinical Trial
About Diva Expertise
Diva Expertise is an innovative French biotech based in Toulouse, in the Biotechnologies Center of Pierre Potier, specializing in applied research on human adipose tissue.
With more than 15 years of expertise in physiology and physiopathology, Diva Expertise has established itself as a leader in human adipose tissue research. Their high-tech platform provides personalized research support, from cellular studies to human applications.
Adipose tissue, which composes the hypodermis (the third layer of the skin), plays a crucial role in skin homeostasis and serves as a key target for innovative anti-aging solutions.
For more information, visit: https://www.diva-expertise.com .
About Sirona Biochem Corp.
Sirona Biochem is a biotechnology company focusing on innovative cosmetic and dermatology active ingredients with a proprietary platform technology.
Sirona specializes in stabilizing carbohydrate molecules to improve their efficacy and safety. Its patented compounds are licensed to leading companies worldwide, generating revenue through licensing fees, milestone payments, and royalties.
Sirona's laboratory, TFChem , is based in France and has received multiple French national scientific awards and grants from the European Union and French government.
For more information, visit: www.sironabiochem.com .
Contact Information
Investor Enquiries:
Christopher Hopton
Chief Financial Officer
(604) 641-4466
info@sironabiochem.com
Forward-Looking Statements
This news release includes certain statements that may be deemed "forward-looking statements". All statements in this new release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include market prices, continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ
materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company's management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change.
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AMGEN ANNOUNCES SENIOR EXECUTIVE RESEARCH APPOINTMENT
Howard Chang , M.D., Ph.D., Joins as Senior Vice President of Research and Chief Scientific Officer
Amgen (NASDAQ:AMGN) today announced that Howard Chang M.D., Ph.D., will join the company as senior vice president of Research, effective Dec. 16, 2024 . Chang will also assume the title and responsibility of serving as Amgen's chief scientific officer, reporting to Jay Bradner M.D., executive vice president of Research and Development.
"Howard is one of our generation's foremost physician-scientists, with expertise in human genetics and a profound ability to distill complex disease biology into clarified targets," Bradner said. "Leading Research at Amgen is a vital role that shapes the disease-altering therapies we pursue for patients. Howard's high-technology approach to science, coupled with his groundbreaking research in gene control, cancer biology and stem cell biology, complements the work we do every day."
Chang will be responsible for establishing and leading all research priorities within Amgen's rare disease, oncology, inflammation and cardiometabolic therapeutic areas. He will also oversee operations in key research hubs from San Francisco to Thousand Oaks , and across the company's global network of specialized sites in Reykjavik , Copenhagen , Munich , British Columbia , and Maryland .
Chang succeeds the highly distinguished Ray Deshaies , Ph.D., former senior vice president of Research, whose departure was announced earlier this year.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2023, Amgen was named one of "America's Greatest Workplaces" by Newsweek, one of "America's Climate Leaders" by USA Today and one of the "World's Best Companies" by TIME.
For more information, visit Amgen.com and follow us on X (formerly known as Twitter), LinkedIn , Instagram , TikTok , YouTube and Threads .
Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico , and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
CONTACT: Amgen, Thousand Oaks
Madison Howard , 773-636-4910 (media)
Elissa Snook , 609-251-1407 (media)
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Cardiol Therapeutics' Phase II MAvERIC-Pilot Clinical Results in Recurrent Pericarditis Presented at the American Heart Association Scientific Sessions 2024
Marked and rapid reductions in both pericarditis pain and inflammation
maintained throughout the 26-week study
Episodes of pericarditis per year substantially reduced
MAvERIC-Pilot results support advancing CardiolRx™ into the Phase II/III MAVERIC-2
and the Phase III MAVERIC-3 clinical trials
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, today reported clinical results from its Phase II open-label MAvERIC-Pilot study investigating the impact of CardiolRx™ administered to patients with symptomatic recurrent pericarditis. The data showed that the marked improvements in both pericarditis pain and inflammation, previously reported at the 8-week primary endpoint, were maintained throughout the extension period of the 26-week study. The data were included in an oral presentation as part of the Laennec Clinician-Educator Award & Lecture at the American Heart Association Scientific Sessions 2024. Dr. S. Allen Luis, Co-Director of the Pericardial Diseases Clinic and Associate Professor of Medicine in the Department of Cardiovascular Medicine at the Mayo Clinic, presented on behalf of the MAvERIC-Pilot investigators. These findings support the initiation of a Phase III trial (MAVERIC-3), designed to assess CardiolRx™ for the treatment of pericarditis patients to prevent recurrence. The MAVERIC-3 trial is expected to run in parallel with the recently announced MAVERIC-2 Phase IIIII trial designed to evaluate the impact of CardiolRx™ in recurrent pericarditis patients following cessation of interleukin-1 blocker therapy.
"The data reported today show that patients enrolled in MAvERIC-Pilot, despite the severity of their disease, experienced clinically relevant and rapid reductions in both their pericarditis pain and C-reactive protein levels that were maintained throughout the study. In addition, results demonstrated a substantial reduction in pericarditis episodes per year as compared to the patients' historical event rate prior to the study. Importantly, treatment was shown to be safe and well tolerated in a population who presented with significant disease burden," said Dr. S. Allen Luis, Co-Director of the Pericardial Diseases Clinic and Associate Professor of Medicine in the Department of Cardiovascular Medicine at the Mayo Clinic. "I look forward to further investigation in the upcoming Phase II/III and Phase III clinical trials."
The MAvERIC-Pilot study enrolled 27 participants (average age 53 years; 67% female) at eight clinical sites across the United States. Average disease duration and the number of pericarditis episodes per year prior to trial entry were 2.7 years and 5.8 events per year, respectively. Baseline pericarditis pain score averaged 5.8 out of 10 and the C-reactive protein ("CRP") level averaged 2.0 mg/dL. In addition to pericarditis chest pain, other manifestations of pericarditis-confirmed diagnosis were pericardial effusion in 21 patients (78%), pericardial rub in 4 (15%), and ST-segment elevation or PR depression in 5 (19%). Stable doses of baseline medications for recurrent pericarditis, in any combination, included colchicine (85% of patients), non-steroidal anti-inflammatory drugs (78%), and corticosteroids (41%). The 26-week study consisted of an 8-week treatment period ("TP") followed by an 18-week extension period ("EP"). In the first 10 days of the TP, CardiolRx™ was added to baseline medications for recurrent pericarditis and up-titrated to 10 mg/kg twice daily, or the maximum tolerated dose. Throughout the TP, patients continued receiving this concomitant therapy but were weaned off baseline medications during the EP to assess pericarditis recurrence while on CardiolRx™ monotherapy.
Summary of results:
- Primary endpoint of patient-reported pericardial pain on an 11-point numerical rating scale from 0-10 showed a mean reduction of 3.7, from 5.8 at baseline (range of 4 to 10) to 2.1 (range of 0 to 6) at week 8.
- Median time to resolution or near resolution of pain (defined as a score of ≤ 2) was rapid and was observed just 5 days following initiation of CardiolRx™ treatment.
- Reduction in pain was maintained throughout the duration of the trial with a mean reduction of 4.3, from 5.8 at baseline to 1.5 at week 26.
- At week 8, 93% (25/27) of patients reported a pain score reduction.
- CRP normalized (≤0.5 mg/dL) at week 8 in 80% (8/10) of the patients with a baseline CRP of ≥1 mg/dL, with a substantial mean reduction of 5.4 mg/dL being observed (5.7mg/dL to 0.3 mg/dL).
- CRP levels for the entire group of patients were reduced from 2.0 mg/dL at baseline to 0.74 and 0.55 at weeks 8 and 26 respectively, with a median time to CRP normalization of 21 days.
- Freedom from recurrence was maintained in 71% (17/24) of patients during the EP when CardiolRx™ was continued and patients were weaned off baseline medications. For those patients experiencing a recurrence the median time to an episode was 7.7 weeks during the EP.
- Number of pericarditis episodes per year was markedly reduced from 5.8 prior to study to 0.9 during the study.
- CardiolRx™ was shown to be safe and well tolerated with eighty-nine percent of patients (24/27) progressing to the EP and overall study drug compliance reported at 95%.
"The compelling results from MAvERIC-Pilot showed that CardiolRx™ resulted in marked and rapid reductions in pericarditis pain and inflammation in patients with a high degree of disease burden as well as a striking decrease in pericarditis episodes per year. The notable impact of CardiolRx™ on these important clinical endpoints demonstrates its potential to offer a more accessible and non-immunosuppressive therapeutic option for tens of thousands of pericarditis patients," said David Elsley, President and CEO of Cardiol Therapeutics. "These results further support advancing our late-stage MAVERIC clinical development program comprising our recently announced Phase II/III MAVERIC-2 trial as well as our planned MAVERIC-3 Phase III trial. Undertaking both trials in parallel provides the exciting opportunity for CardiolRx™ to address the unmet needs of patients in multiple segments that encompass a broad proportion of the pericarditis population."
MAvERIC-PILOT Phase II Study
To be eligible for enrollment in MAvERIC-Pilot, adult patients (≥18 years) were required to present with at least their third pericarditis episode, which included symptomatic pericarditis chest pain with a numerical rating scale ("NRS") pain score ≥4 (on an 11-point numerical rating scale ("NRS") of 0-10), together with either an elevated level of CRP ≥1 mg/dL, a clinical marker of inflammation, or evidence of pericardial inflammation assessed by cardiac imaging with or without elevated CRP. NRS is a validated instrument used to assess patient-reported pericarditis pain. Zero represents 'no pain at all', whereas the upper limit of 10 represents 'the worst pain ever possible'. At baseline eligible patients were permitted to be receiving stable doses of concomitant medications for recurrent pericarditis (non-steroidal anti-inflammatory drugs and/or colchicine and/or oral corticosteroid therapy in any combination).
Pericarditis
Pericarditis refers to inflammation of the pericardium (the membrane or sac that surrounds the heart) frequently resulting from a viral infection. Following that initial episode patients may have multiple recurrences, and the primary goal of treatment is recurrence prevention. Symptoms include debilitating chest pain, shortness of breath and fatigue, resulting in physical limitations, reduced quality of life, emergency department visits, and hospitalizations. Significant accumulation of pericardial fluid and scarring can progress to life-threatening constriction of the heart. The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention. On an annual basis, the number of patients in the United States having experienced at least one recurrence is estimated at 38,000. Approximately 60% of patients with multiple recurrences (>1) still suffer for longer than two years, and one third are still impacted at five years. Hospitalization due to recurrent pericarditis is often associated with a 6-8-day length of stay and cost per stay is estimated to range between $20,000 and $30,000 in the United States.
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The Company's lead small molecule drug candidate, CardiolRx™ (cannabidiol) oral solution, is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease. It is recognized that cannabidiol inhibits activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis, and heart failure.
Cardiol has received Investigational New Drug Application authorization from the United States Food and Drug Administration ("US FDA") to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two diseases affecting the heart: recurrent pericarditis and acute myocarditis. The MAVERIC Program in recurrent pericarditis, an inflammatory disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations, comprises the Phase II MAvERIC-Pilot study (NCT05494788), the Phase II/III MAVERIC-2 trial, and the planned Phase III MAVERIC-3 trial. The ARCHER trial (NCT05180240) is a Phase II study in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years of age. The US FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, which includes recurrent pericarditis.
Cardiol is also developing CRD-38, a novel subcutaneously administered drug formulation intended for use in heart failure – a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.
For more information about Cardiol Therapeutics, please visit cardiolrx.com.
Cautionary statement regarding forward-looking information:
This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward looking information contained herein may include, but is not limited to statements regarding the Company's plans to expand the MAVERIC clinical development program and advance CardiolRx™ into the Phase II/III MAVERIC-2 and the Phase III MAVERIC-3 clinical trials, the Company's plans to conduct the MAVERIC-2 and MAVERIC-3 studies in parallel, the MAVERIC-3 Phase III study being designed to assess CardiolRx™ for the treatment of the broader population of pericarditis patients to prevent recurrence, the Company's focus on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, the molecular targets and mechanism of action of the Company's product candidates, the Company's intended clinical studies and trial activities and timelines associated with such activities, including the Company's plan to complete the Phase III study in recurrent pericarditis with CardiolRx, and the Company's plan to advance the development of CRD-38, a novel subcutaneous formulation of cannabidiol intended for use in heart failure. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission and Canadian securities regulators on April 1, 2024, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information, and such information may not be appropriate for other purposes. Any forward-looking information speaks only as of the date of this press release and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Supplement, the accompanying Base Prospectus and the documents incorporated by reference therein.
For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/230401
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